Treatment of Knee Osteoarthritis (KOA) by Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) Into Joint Cavity

NCT ID: NCT06109220

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2024-12-30

Brief Summary

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The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stage of arthritis

Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower

Group Type EXPERIMENTAL

Stromal vascular fraction,SVF

Intervention Type BEHAVIORAL

SVF was injected into the knee cavity

Interventions

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Stromal vascular fraction,SVF

SVF was injected into the knee cavity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The age range is 20-70 years old
* Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
* The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ
* Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus
* The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items

Exclusion Criteria

* Patients with nonunion or displaced fractures around defective cartilage
* Pregnant or lactating women
* Autoimmune disease
* Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications)
* The patients had severe neurological diseases affecting the evaluation of postoperative results
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanyan Jia

Role: CONTACT

+862984771794

Facility Contacts

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Dawei Zhang, Doctor

Role: primary

+862984771012

Other Identifiers

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KY20232112-X-1

Identifier Type: -

Identifier Source: org_study_id

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